The third quarter in the life sciences space showed that business is generally proceeding as usual, with large pharma players successfully acquiring or licensing in clinical stage assets without running into antitrust delays. That said, even these inherently procompetitive deals appear to be receiving at least some attention from the…
The U.S. Food and Drug Administration’s (“FDA” or “the Agency”) Center for Devices and Radiological Health (“CDRH”) recently announced the launch of its Total Product Life Cycle Advisory Program (“TAP”) Pilot. The first phase of this voluntary initiative, called TAP Pilot Soft Launch, will be conducted during fiscal year (“FY”)…
Recent merger enforcement in the pharmaceutical space continues to follow traditional principles and modes of analysis. However, with a new 3-to-2 Democratic majority, it is increasingly likely that the Federal Trade Commission’s enforcement actions will reflect more aggressive theories that were previously advocated only in dissenting statements. Recent behavioural enforcement…
On September 28, 2022, the U.S. Food and Drug Administration (“FDA” or “the Agency”) issued its long-awaited final guidance, “Clinical Decision Support Software” (the “CDS Guidance”). The CDS Guidance follows the Agency’s September 2019 draft guidance of the same name (the “Draft Guidance”) and seeks to clarify several key concepts…
The new Director of the U.S. Patent and Trademark Office (USPTO), Katherine Vidal, published a stern reminder regarding the duties of disclosure and reasonable inquiry during examination of a patent application, including reexamination, reissue, and proceedings before the Patent Trial and Appeal Board (PTAB) (87 FR 45764 (July 29, 2022)). …
Goodwin’s Financial Restructuring partner Simon Thomas and counsel Oonagh Steel, with contributions from Life Sciences partners Sophie McGrath, Andrew Harrow and Tim Worden, have recently published a piece of thougtht leadership titled “Restructuring and insolvency in the life sciences sector: Q&A” The Q&A discusses the sector-specific issues and risks that…
Although the second quarter did not feature any life sciences enforcement action by the FTC, there was plenty of news in and around the space. The FTC held a detailed “virtual workshop” as part of its pharmaceutical merger task force and news emerged of a potential Merck-Seagen deal that could…
On August 16, President Biden signed the Inflation Reduction Act of 2022 into law,[1] which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement and Modernization Act of 2003. The healthcare-related portions of the law introduce many important changes, most notably…
The Goodwin Propsci team has partnered with several well-known companies for a short video series that explores what’s happening in the real estate life sciences industry. In our latest installment, Johannes Fruehauf, CEO of LabCentral/BioLabs, joins Goodwin’s Nicole Riley and Jim Barrett. LabCentral/BioLabs is a first-of-its-kind shared laboratory space designed as a launchpad for high-potential life…
President Biden’s Executive Order on Promoting Competition in the American Economy, 86 FR 36987 (2021), expressed concerns about the patent system being misused to unnecessarily inhibit or delay entry of generic drugs or biologics to the marketplace for years, denying Americans access to lower cost drugs. The President called for…